A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Condition(s) studied

Investigational drug(s) / intervention(s)

Efruxifermin: Administered by subcutaneous (SC) injection

Placebo: Administered by SC injection

Study summary

The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.

Eligibility

Primary outcome measure(s)

• Extent of exposure — 52 Weeks
  A participant's extent of exposure to study drug (weeks) will be generated from the data recorded in the study drug administration eCRF.
• Number of participants with adverse events — 52 Weeks
  An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study drug.
• Number of participants with adverse events by severity — 52 Weeks
  All AEs, both serious and non-serious, will be assessed for severity using the Common Terminology Criteria for Adverse Events v5.0.
• Number of participants with clinically significant changes in clinical assessments — 52 Weeks
  Clinical assessments include clinical laboratory tests, electrocardiogram, ultrasounds, vital sign assessments, and concomitant medication usage.

Trial sites (211)

+ 171 more sites — see the full list on the official registry below.

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